Regulatory Decision Summary for Aimovig
The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.
Type of submission:
What was the purpose of this submission?
The purpose of this submission is to seek market authorization for Aimovig (erenumab) for the prevention of migraine in adults. After evaluation of the submitted data package, Health Canada authorized Aimovig for the prevention of migraine in adults who have at least 4 migraine days per month.
Why was the decision issued?
Migraine is a major cause of disability in Canada and around the world. Aimovig demonstrated a statistically significant and clinically meaningful difference in the reduction of monthly migraine days. Sufficient evidence was provided to support its indication for prevention of migraine in adults who have at least 4 migraine days per month. With the addition of Aimovig to the available treatment options for Canadians, patients and healthcare practitioners will have additional choices when considering management strategies for migraine.
The frequency of adverse events was roughly balanced across different treatment groups in clinical studies. The most common adverse events were injection site reactions, constipation, muscle spasm, and pruritus. The safety profile of Aimovig is acceptable for the sought indication. Some uncertainty remains with regards to the safety and efficacy of Aimovig for geriatrics, pediatrics, pregnant and breastfeeding patients among others. These limitations of data have been adequately mitigated through labelling. Based on the data reviewed at this time, a theoretical risk of increased vascular events was not evident.
The recommended dose of Aimovig is 70 mg administered once monthly. Some patients may benefit from a dose of 140 mg once monthly administered as two consecutive subcutaneous injections of 70 mg. The overall benefit/risk profile is considered favourable for Aimovig when used for prevention of migraine in adults who have at least 4 migraine days per month.
Approved; issued Notice of Compliance in accordance with the Food and Drug Regulations.